Federal Register / Vol. 71, No.

128 / Wednesday, July 5, 2006 / Notices 38169

DC 20447, Attn: ACF Reports Clearance comments and suggestions submitted OMB No.: New Collection.
Officer. E-mail address: within 60 days of this publication. Description: The data collected by
infocollection@acf.hhs.gov. All requests Dated: June 27, 2006. form OCSE–75 are used to prepare the
should be identified by the title of the Robert Sargis, OCSE preliminary and annual data
information collection.
Reports Clearance Officer. reports. In addition, Tribes
The Department specifically requests
comments on: (a) Whether the proposed [FR Doc. 06–5978 Filed 7–3–06; 8:45 am] administering CSE programs under Title
collection of information is necessary BILLING CODE 4184–01–M IV–D of the Social Security Act are
for the proper performance of the required to report program status and
functions of the agency, including accomplishments and submit the
DEPARTMENT OF HEALTH AND OCSE–75 report annually.
whether the information shall have
HUMAN SERVICES
practical utility; (b) the accuracy of the Respondents: Tribal Child Support
agency’s estimate of the burden of the Administration for Children and Enforcement Organizations or the
proposed collection of information; (c) Families Department/Agency/Bureau responsible
the quality, utility, and clarity of the for Child Support Enforcement in each
information to be collected; and (d) Proposed Information Collection Tribe.
ways to minimize the burden of the Activity; Comment Request Annual Burden Estimates:
collection of information on
respondents, including through the use Proposed Projects
of automated collection techniques or Title: OCSE–75 Tribal Child Support
other forms of information technology. Enforcement Program Annual Data
Consideration will be given to Report.

Number of re- Average burden

Number of re- Total burden
Instrument sponses per re- hours per re-
spondents hours
spondent sponse

OCSE–75 ................................................................................. 9 1 2.5 22.5

Estimated Total Annual Burden agency’s estimate of the burden of the Head Start Grantees and Current or
Hours: 22.5. proposed collection of information; (c) Prospective Delegate Agencies.
In compliance with the requirements the quality, utility, and clarity of the OMB No.: 0980–0242.
of Section 3506(c)(2)(A) of the information to be collected; and (d)
Paperwork Reduction Act of 1995, the ways to minimize the burden of the Description: Section 646 of the Head
Administration for Children and collection of information on Start Act requires the Secretary of
Families is soliciting public comment respondents, including through the use Health and Human Services to prescribe
on the specific aspects of the of automated collection techniques or a timeline for conducting administrative
information collection described above. other forms of information technology. hearings when adverse actions are taken
Copies of the proposed collection of Consideration will be given to or proposed against Head Start and
information can be obtained and comments and suggestions submitted Early Head Start grantees and delegate
comments may be forwarded by writing within 60 days of this publication. agencies. The Office of Head Start is
to the Administration for Children and proposing to renew, without changes,
Dated: June 27, 2006.
Families, Office of Administration, this rule, which implements these
Robert Sargis,
Office of Information Services, 370 requirements and which prescribes
L’Enfant Promenade, SW., Washington, Reports Clearance Officer.
[FR Doc. 06–5979 Filed 7–3–06; 8:45 am]
when a grantee must submit certain
DC 20447, Attn: ACF Reports Clearance information and what that information
Officer. E-mail address: BILLING CODE 4184–01–M
shall include.
infocollectionrsargis@acf.hhs.gov. All
requests should be sent to Respondents: Head Start and Early
infocollection@acf.hhs.gov identifying DEPARTMENT OF HEALTH AND Head Start grantees and Delegate
the request by the title of the HUMAN SERVICES Agencies.
information collection. Annual Burden Estimates:
The Department specifically requests Administration for Children and
comments on: (a) Whether the proposed Families
collection of information is necessary
Submission for OMB Review;
for the proper performance of the
Comment Request
functions of the agency, including
whether the information shall have Title: 45 CFR Part 1303—Appeal
practical utility; (b) the accuracy of the Procedures for Head Start and Early

Number of re- Average burden

Number of re- Total burden
Instrument sponses per re- hours per re-
spondents hours
spondent sponse
rwilkins on PROD1PC63 with NOTICES

Rule .......................................................................................... 20 1 26 520

VerDate Aug<31>2005 19:34 Jul 03, 2006 Jkt 205001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\05JYN1.SGM 05JYN1
 38170 Federal Register / Vol. 71, No. 128 / Wednesday, July 5, 2006 / Notices
Estimated Total Annual Burden
Hours: 520.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Administration, Office of Information
Services, 370 L’Enfant Promenade, SW.,
Washington, DC 20447, Attn: ACF
Reports Clearance Officer. All requests
should be identified by the title of the
information collection. E-mail address:
infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, 725 17th Street, NW.,
Washington, DC 20503, Attn: Desk
Officer for ACF. E-mail address:
Katherine_T._Astrich@omb.eop.gov.
Dated: June 26, 2006.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 06–5980 Filed 7–3–06; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004E–0396]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; TAXUS EXPRESS
Paclitaxel-Eluting Coronary Stent
System
AGENCY: Food and Drug Administration,
HHS.
ACTION: Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for TAXUS
EXPRESS Paclitaxel-Eluting Coronary
Stent System and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of an application to the
Director of Patents and Trademarks,
Department of Commerce, for the
rwilkins on PROD1PC63 with NOTICES
extension of a patent which claims that
medical device.
ADDRESSES: Submit written comments
and petitions to the Division of Dockets
Management (HFA–305), Food and Drug
VerDate Aug<31>2005 19:34 Jul 03, 2006 Jkt 205001
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to http://
www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy (HFD–7), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–594–2041.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) and the Generic Animal Drug and
Patent Term Restoration Act (Public
Law 100–670) generally provide that a
patent may be extended for a period of
up to 5 years so long as the patented
item (human drug product, animal drug
product, medical device, food additive,
or color additive) was subject to
regulatory review by FDA before the
item was marketed. Under these acts, a
product’s regulatory review period
forms the basis for determining the
amount of extension an applicant may
receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For medical devices,
the testing phase begins with a clinical
investigation of the device and runs
until the approval phase begins. The
approval phase starts with the initial
submission of an application to market
the device and continues until
permission to market the device is
granted. Although only a portion of a
regulatory review period may count
toward the actual amount of extension
that the Director of Patents and
Trademarks may award (half the testing
phase must be subtracted as well as any
time that may have occurred before the
patent was issued), FDA’s determination
of the length of a regulatory review
period for a medical device will include
all of the testing phase and approval
phase as specified in 35 U.S.C.
156(g)(3)(B).
FDA recently approved for marketing
the medical device TAXUS EXPRESS
Paclitaxel-Eluting Coronary Stent
System. TAXUS EXPRESS Paclitaxel-
Eluting Coronary Stent System is
indicated for improving luminal
diameter for the treatment of de novo
lesions ≤28 mm in length in native
coronary arteries ≥2.5 to ≤3.75 mm in
diameter. Subsequent to this approval,
the Patent and Trademark Office
received a patent term restoration
application for TAXUS EXPRESS
Paclitaxel-Eluting Coronary Stent
System (U.S. Patent No. 5,716,981) from
Angiotech Phamaceuticals, Inc., and the
Patent and Trademark Office requested
FDA’s assistance in determining this
patent’s eligibility for patent term
PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\05JYN1.SGM
restoration. In a letter dated February
24, 2006, FDA advised the Patent and
Trademark Office that this medical
device had undergone a regulatory
review period and that the approval of
TAXUS EXPRESS Paclitaxel-Eluting
Coronary Stent System represented the
first permitted commercial marketing or
use of the product. Thereafter, the
Patent and Trademark Office requested
that FDA determine the product’s
regulatory review period.
FDA has determined that the
applicable regulatory review period for
TAXUS EXPRESS Paclitaxel-Eluting
Coronary Stent System is 716 days. Of
this time, 456 days occurred during the
testing phase of the regulatory review
period, while 260 days occurred during
the approval phase. These periods of
time were derived from the following
dates:
1. The date an exemption under
section 520(g) of the Federal Food, Drug,
and Cosmetic Act involving this device
became effective: March 21, 2002. The
applicant claims that the investigational
device exemption (IDE) required under
section 520(g) of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
360j(g)) for human tests to begin became
effective on October 25, 2001. However,
FDA records indicate that the IDE was
determined substantially complete for
clinical studies to have begun on March
21, 2002, which represents the IDE
effective date.
2. The date the application was
initially submitted with respect to the
device under section 515 of the act (21
U.S.C. 360e): June 19, 2003. The
applicant claims February 25, 2003, as
the date the premarket approval
application (PMA) for TAXUS EXPRESS
Paclitaxel-Eluting Coronary Stent
System (PMA P030025) was initially
submitted. However, FDA records
indicate that PMA P030025 was
submitted in modules and was not
substantially complete until the final
submission of clinical data on June 19,
2003.
3. The date the application was
approved: March 4, 2004. FDA has
verified the applicant’s claim that PMA
P030025 was approved on March 4,
2004.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the U.S. Patent and
Trademark Office applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 807 days of patent
term extension.
Anyone with knowledge that any of
the dates as published are incorrect may
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